Brief Article
Copyright ©2012 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastrointest Pharmacol Ther. Feb 6, 2012; 3(1): 1-6
Published online Feb 6, 2012. doi: 10.4292/wjgpt.v3.i1.1
Non-bismuth quadruple therapy for first-line Helicobacter pylori eradication: A randomized study in Japan
Ayako Yanai, Kei Sakamoto, Masao Akanuma, Keiji Ogura, Shin Maeda
Ayako Yanai, Department of Gastroenterology, Toranomon Hospital Kajigaya, 1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa 213-8587, Japan
Ayako Yanai, Kei Sakamoto, Masao Akanuma, Division of Gastroenterology, Institute for Adult Diseases, Asahi Life Foundation, 1-6-1 Marunouchi, Chiyoda-ku, Tokyo 100-0005, Japan
Keiji Ogura, Department of Gastroenterology, Tokyo Metropolitan Police Hospital, 4-22-1 Nakano, Nakano-ku, Tokyo 164-8541, Japan
Shin Maeda, Department of Gastroenterology, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
Author contributions: Maeda S conceived the project; Yanai A and Maeda S designed the study; Yanai A, Sakamoto K, Akanuma M and Maeda S participated in the study and acquired data; Yanai A led the analysis; all authors contributed to the analysis and interpretation of the data; Yanai A drafted the initial manuscript; and Ogura K and Maeda S commented on the drafts and approved the final manuscript.
Correspondence to: Ayako Yanai, MD, PhD, Department of Gastroenterology, Toranomon Hospital Kajigaya, 1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa 213-8587, Japan. a-yanai@toranomon.gr.jp
Telephone: +81-44-8775111 Fax: +81-44-8775333
Received: August 2, 2011
Revised: January 29, 2012
Accepted: February 3, 2012
Published online: February 6, 2012
Abstract

AIM: To find the way to improve the eradication rate of first-line therapy in Japanese patients.

METHODS: We prospectively compared the effectiveness of 7-d quadruple therapy to standard 7 d triple therapy in Japanese patients infected with Helicobacter pylori (H. pylori). One hundred and nineteen patients were randomly assigned to receive 7-d non-bismuth quadruple therapy with lansoprazole, amoxicillin, clarithromycin and metronidazole (LACM7) or 7-d triple therapy with lansoprazole, amoxicillin and clarithromycin (LAC7). After three months, H. pylori status was analyzed by 13C-urea breath test. Incidence rates of adverse events were evaluated by use of questionnaires.

RESULTS: By intention-to-treat (ITT) analysis, the eradication rate in the LACM7 group was 94.9%, which was significantly higher than the LAC7 group (68.3%, P < 0.001). Per protocol analysis also showed a significantly higher eradication rate in the LACM7 group (98.3%) than the LAC7 group (73.2%, P < 0.001). Nevertheless, the incidence of serious adverse events did not differ between the two groups (RR: 1.10, 95% CI: 0.70-1.73, P = 0.67).

CONCLUSION: Seven day non-bismuth quadruple therapy (LACM7) was superior to standard 7-d triple therapy (LAC7) for first-line eradication.

Keywords: Helicobacter pylori; Eradication; First-line treatment; Non-bismuth quadruple therapy; Prospective study